Expanded Access Working Group

The Working Group


To identify and address practical, ethical, and regulatory issues that arise from the use, and potential misuse, of the expanded access pathway by various CGT stakeholders. The Working Group will develop informed perspectives on expanded access that will help ISCT as it generates educational resources that promote innovation in translational research while upholding the highest ethical standards.

The Committee

Headshot of Patricia Zettler


Patricia J. Zettler, JD
January 2022 - Present

The Ohio State University
United States


Aaron Levine, PhD, MPhil
Georgia Institute of Technology
United States

Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP
Baylor College of Medicine
United States

Beth Roxland, JD, MBioethics
Roxland Consultants Ltd.
United States

Karen Nichols, Esq.
Vertex Pharmaceuticals
United States

Laertis Ikonomou, PhD
The State University of New York at Buffalo
United States

Leigh Turner, PhD
University of California Irvine
United States

OTAT Liaison

Wilson Bryan, MD
Appointed FDA representative
Director of the Office of Tissues and Advanced Therapies
United States